Efficacy Study on Quality of Life Criteria of a Digital Application on Any Cellphone (OnKO-Tips&Tricks) for Adolescents and Young Adults Diagnosed With Cancer

NCT ID: NCT05350631

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2026-07-31

Brief Summary

Approximately 2,200 cancers per year in France are diagnosed within the adolescents and young adults population (15-25 years old, AYA). The cancer plans and the INCA recommend support during and after cancer treatment, taking into account both medical and psycho-social specificities related to age (support care, school learning/training and professional integration, fertility preservation, therapeutic education, addictology, sexology...). In this context, AJA teams have been developed in which the Nurse Coordinators (IDEC) play a fundamental role. These Nurse Coordinators are available to young patients, their families and the professionals who accompany follow them in their therapeutic journey. Their main missions are to assess the specific needs of these young people and their loved ones, to inform, orient and participate in the coordination of their care by providing psychosocial and paramedical solutions to these young patients. The circular of 30/05/2016 on the coordinated regional organization of care for AJAs supports the development of connected health tools for AJAs. This population is adept to new technologies, social networks allowing them to continue to be informed and remain integrated to the outside world while helping them prepare for life after cancer.

In this context, our team initiated the development of a digital application compatible for any cellphone OnKO-Tips&Tricks meeting these criteria of necessity with the company CAPCOD. We would want to move on to a validation stage by carrying out a national multicenter efficacy study in AJA mobile units by comparing two groups of patients: users/non-users of this digital tool on a main criterion of quality of life after using it for 6 months. As it should promote autonomy and integration into the care pathway as well as active participation in therapeutic education programs (TPE), these different items will be evaluated as secondary endpoints of our study

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

only follow-ups consultations, phone contact and TVE workshop with the AJA mobile team centralized by the IDEC

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental

using a digital tool in addition to follow-ups by consultations, phone contact and PTE workshop with the AJA mobile team centralized by the IDEC

Group Type: EXPERIMENTAL

OnKO-Tips&Tricks digital phone application

Intervention Type: OTHER

Using daily OnKO-Tips\&Tricks digital phone application

Interventions

OnKO-Tips&Tricks digital phone application

Using daily OnKO-Tips\&Tricks digital phone application

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient age ≥ 15 years and ≤ 25 years
• Diagnosed with solid or blood cancers less than 1 month old or patient with relapsed cancer more than 5 years after completion of initial treatment
• Follow-up at one of the participating study centers
• Informed and signed consent from the patient and, if the subject is a minor, from the holders of parental authority
• Inclusion in the study at the latest at the time of initiation of chemotherapy or radiotherapy
• Patient agrees to 12-month post-inclusion follow-up
• Patient agreeing to complete all study questionnaires
• Patient with a cellphone capable of downloading the app (developed for all types of cellphones)
• Affiliated to a social health insurance plan

Exclusion Criteria

• Patient deprived of liberty by a judicial or administrative decision
• Patient with protected person status
• Patient who does not understand, speak or write French
• Patient unable to understand the follow-up protocol according to the investigating physician or the IDEC of the AJA unit
• Patient with a scheduled hospitalization of at least 5 weeks during study participation

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, France, France

Hôpital enfant-adolescent

Nantes, France, France

CHU de Nice Hôpital Archet 2

Nice, France, France

CHU Reims - Hôpital Maison Blanche

Reims, France, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, France

Assistance Publique - Hôpitaux de Marseille

Marseille, , France

CHU Rennes Hôpital Sud

Rennes, , France

Institut de Cancérologie de l'Ouest

Saint-Herblain, , France

Institut de Cancerologie Strasbourg Europe

Strasbourg, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

8360

Identifier Type: -

Identifier Source: org_study_id